Navigation Links
New Study Demonstrates Safety of Balloon Sinuplasty(TM) Technology in Pediatric Patients Suffering From Chronic Sinusitis

MENLO PARK, Calif., March 2 /PRNewswire/ -- A recently published study in the American Journal of Rhinology and Allergy demonstrates Balloon Sinuplasty™ technology to be safe when used by physicians in pediatric patients. Known as the INTACT study, this is a prospective, non-randomized, multicenter study and was sponsored by Acclarent, Inc.

Thirty-two pediatric patients, between the ages of 2 and 11, underwent minimally invasive sinus surgery with the Balloon Sinuplasty™ technology after previously failing medical management for 3-6 months and showing CT evidence of chronic sinusitis. These patients were followed for one year and effectiveness was assessed using the validated SN-5 quality of life questionnaire.

At one year follow up, 87% of patients reported improvement in their sinus symptoms. Statistically significant improvements in patient quality of life were maintained through one year.  No adverse events were observed at any time point throughout the study.  The authors concluded that when patients are appropriately selected, preliminary results indicate that sinus ostial dilation using balloon catheters in children has an excellent safety profile and may be an effective minimally invasive treatment option to relieve sinus ostial obstruction.

Balloon Sinuplasty™ technology is used to restore normal sinus drainage by widening constricted sinus passages with specially designed catheters and balloons.  The technology has been used to treat over 100,000 patients since receiving FDA clearance in 2005 and can be used alone or with standard surgical instrumentation.  Since 2005, more than 5,600 sinus surgeons have been trained on the use of Balloon Sinuplasty™ technology.

The Center for Disease Control data reports sinusitis is among the most common illnesses in the U.S., affecting an estimated 37 million Americans and leading to 500,000 surgeries a year.  Pediatric patients make up 22% of all office visits for chronic sinusitis(1).  Symptoms include repeated infections, headaches, facial pain, persistent congestion, cough and fatigue.

"The INTACT study affirms the safety of minimally invasive sinus surgery with Balloon Sinuplasty™ technology in children. The use of Balloon Sinuplasty™ technology at the time of adenoidectomy or after failed adenoidectomy is an option that should be considered prior to traditional sinus surgery," said Hassan Ramadan, M.D., MSc, FACS of West Virginia University, and lead author of the INTACT study.

All medical procedures contain risks.  Although rare, the risks associated with Balloon Sinuplasty™ technology include tissue and mucosal trauma, infection, or possible optic injury.  Consult your physician for a full discussion of risks and benefits to determine whether this procedure is right for you or your child.

About Acclarent

Acclarent, Inc., a business unit of Ethicon, Inc. (, is a medical device company located in Menlo Park, CA.  Its singular focus is improving patient care in all areas of otolaryngology by designing, developing and commercializing medical devices that address conditions affecting the ear, nose and throat (ENT).  Acclarent is demonstrating this by developing innovative technologies, and investing in clinical studies and physician training. For more information, visit or

American Journal of Rhinology & Allergy, Volume 24, Number 1, January/February 2010 , pp. e54-e56(1)

(1) Benninger, M., Otolaryngology Head and Neck Surgery 2003; 129S: S1-S32

SOURCE Acclarent, Inc.

Back to top



SOURCE Acclarent, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Dendreon Announces Publication of Phase 1 Study Highlighting Immunologic and Clinical Activity of Lapuleucel-T (Neuvenge(R)) in Advanced Breast Cancer Patients
2. EDAP Announces Launch of Clinical Study Combining HIFU and Chemotherapy for Localized Aggressive High Risk Prostate Cancer
3. Cephalon Announces Positive Results from a Pivotal Study of FENTORA in Opioid-tolerant Patients with Non-cancer Breakthrough Pain
4. Allos Therapeutics Initiates Study of PDX in Patients with Cutaneous T-Cell Lymphoma
5. Multiple Myeloma Research Consortium (MMRC) Partners with Novartis to Advance Phase II Study of Deacetylase Inhibitor
6. Potential Safety Issue Identified in Ongoing Phase 2 Clinical Study of HCV-796
7. Study Suggests High-Dose Fish Oil May Significantly Improve Behavior in Children with ADHD
8. MicroDose Announces Positive Results From the QDose Inhaled Insulin Glucose Clamp Study
9. Video: Landmark Study in The Lancet: Patients Treated With Betaseron(R) After First MS Attack Experienced Significant Delay in MS Progression
10. MacroGenics Begins Global Phase 2/3 Protege Study in Recent-onset Type 1 Diabetes Mellitus
11. Sarasotas Roskamp Institute Releases Study Defining a Mechanism for Development of Obesity and the Metabolic Syndrome, Forerunners of Type 2 Diabetes
Post Your Comments:
(Date:6/26/2016)... Ontario , June 27, 2016  VMS Rehab ... Company,s Board will take whatever measures required to build ... Company,s stock which is currently listed on the OTC ... Wexler, Company Chairman and CEO, "We are seeing an ... difficult to understand, not only by the Company, but ...
(Date:6/24/2016)... , June 24, 2016  Global Blood Therapeutics, ... company developing novel therapeutics for the treatment of ... announced the closing of its previously announced underwritten ... at the public offering price of $18.75 per ... were offered by GBT. GBT estimates net proceeds ...
(Date:6/24/2016)... The Academy of Managed Care Pharmacy (AMCP) ... would allow biopharmaceutical companies to more easily share health ... and coverage decisions, a move that addresses the growing ... The recommendations address restrictions in the sharing of ... label, a prohibition that hinders decision makers from accessing ...
Breaking Medicine Technology:
(Date:6/25/2016)... ... 25, 2016 , ... "With 30 hand-drawn hand gesture animations, FCPX users can ... CEO of Pixel Film Studios. , ProHand Cartoon’s package transforms over 1,300 hand-drawn ... X . Simply select a ProHand generator and drag it above media or text ...
(Date:6/25/2016)... ... June 25, 2016 , ... ... recover from injury. Recently, he has implemented orthobiologic procedures as a method for ... is one of the first doctors to perform the treatment. Orthobiologics are substances ...
(Date:6/24/2016)... ... ... A recent article published June 14 on E Online details ... to state that individuals are now more comfortable seeking to undergo not only the ... and cheek reduction. The Los Angeles area medical group, Beverly Hills Physicians (BHP) notes ...
(Date:6/24/2016)... ... June 24, 2016 , ... Marcy was in a crisis. Her son James, eight, ... at his family verbally and physically. , “When something upset him, he couldn’t control his ... it. He would throw rocks at my other children and say he was going to ...
(Date:6/24/2016)... (PRWEB) , ... June 24, 2016 , ... ... now offering micro-osteoperforation for accelerated orthodontic treatment. Dr. Cheng has extensive experience with ... Damon brackets , AcceleDent, and accelerated osteogenic orthodontics. , Micro-osteoperforation is a ...
Breaking Medicine News(10 mins):